Headgear, interface and an assembly

ABSTRACT

This invention relates to a headgear comprising a semi-rigid frame engageable with the head of a user and a releasable connection system for releasable connection with a user interface, wherein the frame extends generally about a rear region of a user&#39;s head, generally about an upper region of a user&#39;s head, and generally about an ear or both ears of a user.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference herein in theirentireties and made a part of the present disclosure.

FIELD OF THE INVENTION

The present invention generally relates to components for medicalsystems for conveying gases to and/or from a patient. In one particularaspect, the invention relates to headgear, a patient interface, or anassembly of headgear and a patient interface as part of a medical systemfor conveying breathable gases to and/or from a patient or as part of abreathing system.

BACKGROUND TO THE INVENTION

Alternative and improved retention systems for positioning, such asfixed positioning, of gas delivery interface systems, such as masks,nasal cannula or other oronasal gas delivery interface units, for a userof the interface are always being sought.

Typically, in infant applications, due to the size of the head of theinfant, adhesive patches or other dermal connection systems are used toposition such gas delivery interfaces. For example, adhesive tape isapplied over the tube or part of a nasal cannula to hold the cannula inplace or an operation position on the infant's face. This causes anumber of problems, such as skin reactions, skin abrasion, or breakdownwhen tape is repeatedly applied and removed, especially when an infantis being cycled between different types of gas therapy.

Many complex systems, including elasticised straps, buckles, tensioners,and other such retaining systems, are utilised in holding or positioningof user interfaces on the face or in preferred installation positions ona user. Therefore, a system for improved ease of application orinstallation of such interfaces for a user, such as by the user or by acarer of the user are desirable. Ease of being able to cycle betweendifferent treatment therapies would also be desirable, especially alsoreducing the need for handling of a user's head or applying andre-applying adhesives, glues, or tapes to the face of the user forpositioning of a gas delivery interface in an operational position.

Further, stresses applied to the head of a user from various complexheadgears may result in stress sores or contact abrasion. Therefore,minimising the overall stresses applied to the head of a user is alsodesirable. Stresses applied to the head or face of a user, depending onwhere tension is exerted from such more complex headgear arrangements,can sometimes result in “snub nosing”. The likelihood of snub nosingpreferably is reduced or eliminated.

In this specification, any references to other patent specifications,other external documents, or other sources of information are generallyfor the purpose of providing a context for discussing the features ofthe invention. Unless specifically stated otherwise, reference to suchexternal documents is not to be construed as an admission that suchdocuments, or such sources of information, in any jurisdiction, areprior art, or form part of the common general knowledge in the art.

Further aspects and advantages of the present invention will becomeapparent from the ensuing description, which is given by way of exampleonly.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a headgearand/or an interface, or an assembly of both a headgear and an interface,which will go at least some way towards addressing the foregoingproblems or which will at least provide the public with a useful choice.

In a first aspect, the present invention may broadly comprise a headgearcomprising

a semi-rigid frame engageable with the head of a user, and

a releasable connection system for releasable connection with a userinterface.

In a further aspect, the present invention may broadly comprise aheadgear comprising

a semi-rigid frame engageable with the head of a user,

a releasable connection system for releasable connection with a userinterface, wherein

the frame extends generally about a rear region of a user's head,generally about an upper region of a user's head, and generally about anear or both ears of a user.

In one embodiment the releasable connection system may be provided on orabout a region of the frame extending generally about the ear or ears ofthe user. In another embodiment the releasable connection system may beprovided on or about a region of the frame extending generally in frontof the ear or ears of the user. In another embodiment the releasableconnection system may be provided as a region at or in front of the earor ears of a user.

Preferably the releasable connection system may be a two-part connectorsystem. More preferably, a first connector part or portion may beprovided by, or on, a region of the headgear, and a second connectorpart or portion may be provided by, or on, a region of (or in attachmentor connection with) a user interface.

In one embodiment the first connector part or portion is one of a hookor a loop of a hook and loop type fastener system, and the secondconnector part or portion is the other of a loop or a hook for the hookand loop type fastener system.

In another embodiment the two-part connector system is a system ofmagnets. Preferably the first connector part or portion is a firstmagnet or series of magnets, and the second connector part or portion isthe other or a second magnet or series of magnets (e.g. such as a magnetor magnets of opposite polarity to the first magnet or series ofmagnets).

In another embodiment, the two-part connector system may be provided bya two-part adhesive, where the first connector part or portion isprovided with an adhesive that is receivable by the second part orportion, or where the second connector part or portion is provided withan adhesive that is receivable by the first part or portion, or wherethe first part or portion provides for the first of a two-part adhesive,and the second part or portion provides for the second of a two-partadhesive, whereby the bringing together of the first and second parts orportions facilitates or enables adhesion between the two parts.Advantageously, the parts are releasably adherable to each other.

Preferably the first part comprises an adhesive and the second part isreceivable of the adhesive or bondable with the adhesive, or the secondpart comprises an adhesive and the first part is receivable of theadhesive or bondable with the adhesive, or both the first and secondparts comprise an adhesive or one part of a two-part adhesive.Optionally, such an adhesive is a releasable adhesive system, or is anon-permanent binding or bonding together of adhesive or adhesivereceiver parts.

Preferably, the user interface may be a gas delivery system or a gasdelivery device. More preferably the user interface may be a device forsupplying of breathable gas to a user. Preferably the user interface maybe any one or any combination of: mask, nasal cannula, oronasal device.Preferably the interface may be connectable to a breathing tube.

In one embodiment the releasable connection system may be of asubstantially low or flat profile. In another embodiment the releasableconnection system may be of a substantially similar profile to theprofile of the frame. Preferably the profile is generally substantiallyplanar or substantially flat (for example, may be planar or flat inprofile).

Preferably the releasable connection system may be an interferenceattachment system. More preferably the interference attachment systemprovides for connection or connectability between a user interface (or apart thereof, or a part connected or attached to a user interface) andone or more of:

the headgear region extending generally about the ear or ears of a user,the headgear region extending generally in front of the ear or ears of auser, the headgear region at or in front of the ear or ears of a user.

Preferably the interference attachment system may be a two-partconnector system as defined above.

In one preferred embodiment, advantageously, the releasable connectionsystem does not utilise pulley strap systems or buckles. Pulley orbuckle type systems can impact on a user's face, particularly an infantface. For example, application of a connection or retention system tootightly on a user's face may contribute to so-called “snub nosing”, suchas when forces are applied to the nose, septum or philtrum.

Preferably the releasable connection system enables connection between auser interface and the headgear, whilst reducing the likelihood of theapplication of tension during installation of the user interface to auser in combination with the headgear.

Preferably the releasable connection system reduces the likelihood ofthe need for application of adhesive, or adhesive tape, to a user's skinfor the installation and placement of a user interface into anoperational position, or may reduce the likelihood of the application ofadhesive to a user's skin in installation or adhesive applied to auser's skin for connection of a user interface.

Preferably the frame extending generally about the ears of the user maypartially or wholly surround or encircle one or both ears. Morepreferably the frame extending about the ear or ears of a user is a loopabout an, or each, ear of the user.

Preferably the headgear may be adjustable.

Preferably the headgear may be provided in a ready-to-receive mode forreceiving the head of a user and/or connecting with or connectableto/with a user interface (or a part or portion thereof).

Preferably the headgear may be provided in a ready-to-receive mode forreceiving a user interface (or a part of a portion thereof).

Preferably the headgear may be adjustable for fitment to a user's head,such as for anatomical adjustment.

Preferably the headgear may be adjustable for different user head sizes.

Preferably the headgear may be adjustable for varying the distance theframe extends between the rear region (or region above the nape of auser's neck) and the portion of the frame that extends generally aboutthe ear or ears of a user.

Preferably the headgear may be adjustable for varying the distance theframe extends between the upper region (or top) of a user's head and theportion of the frame that extends generally about the ear of ears of auser.

Preferably the frame extending generally about the ear or ears of a usermay be adjustable, more preferably the loop about an, or each ear of theuser, may be adjustable, such as adjustable by the size of the loopprovided for encircling partially or wholly the ear or ears of a user.

Preferably the frame may include an adjustment strap or straps.Preferably the adjustment strap or one of the adjustment straps may be apart of the frame positionable generally about the upper region (or top)of the user's head. Alternatively the adjustment strap or one of theadjustment straps may be a part of the frame positionable generallyabout the rear region (or region above the nape of the user's neck).More preferably the adjustment straps may be both a part of the framepositionable generally about the upper region (or top) of the user'shead and the frame positionable generally about the rear region (orabove the nape region of the user's neck).

Preferably the adjustment strap or straps may be of a hook and loop typefastener system for adjustable fastening. More preferably, oralternatively, the adjustment strap or straps comprise or include abuckle arrangement, where an adjustment strap is insertable through abuckle.

Preferably the rear region may be a lower rear region of the user'shead. More preferably the rear region may be a region above the nape ofthe user's neck.

Preferably the upper region may be a region about the top of a user'shead.

Preferably the frame is formed of or from a semi-rigid material.

Preferably the frame is of a self-sustaining shape.

Preferably the frame is supportive of an interface which may beconnected thereto.

Preferably the frame is provided as one-piece or as a single partarticle or is a unitary piece of headgear. For example, the framepreferably is not provided by multiple straps or multiple parts thatmust be assembled or connected together to provide the semi-rigidheadgear.

Preferably the semi-rigid frame may be of a substantially non-elasticconstruction or substantially non-elastic material.

Preferably the frame may be of a substantially self-supporting shapeand/or configuration.

Preferably the frame forms a semi-rigid frame about the head of a user.

Preferably the frame is supportive of an interface which may beconnected thereto.

Preferably the frame provides a substantially self-supporting frame towhich a user interface (or a part thereof, or a part connected orattached to a user interface) may be connectable and supported in-situtherefrom.

Preferably the releasable connection system may be capable of supportingshear and/or pull forces that may be imparted from connection of a userinterface.

Preferably the frame may be of a substantially planar or substantiallyflat profile, the planar or flat profile generally contoured for planaror flat contact with a user's head.

Preferably the frame may be of a non-frayable woven material or fabric.

Preferably the frame may be of a non-woven material or fabric,alternatively may be of a semi-rigid polymer.

Preferably the frame may be formed of a thermoplastic or thermosettingpolymeric material or composites therefrom. Alternatively, the frame maybe formed of or from a weldable polymeric material.

Preferably the frame may be formed from a polyethylene terephthalate(PET), a polyethylene (PE), or polyester.

Preferably the frame may be formed from a non-woven polyethyleneterephthalate (PET)/polyethylene (PE) laminated composite, or anon-woven PET/polyester laminated composite.

Preferably the headgear, or user interface, or both, are for an infant.More preferably, the headgear, or user interface, or both, are sized ordesigned for an infant.

In a further aspect, the present invention may broadly comprise a userinterface comprising adapted for use with the headgear of the aboveaspects.

In a further aspect, the present invention may broadly comprise a userinterface of the above aspect comprising:

a user interfacing part or portion, and releasable connection systempart or portion for releasable connection with a headgear connectablepart or portion.

Preferably the releasable connection system part of portion may beprovided by, or on, a region of (or in attachment or connection with)the user interface.

Preferably the releasable connection system part or portion may beintegral with the user interfacing part or portion or may beover-moulded with the user interfacing part or portion.

Preferably the releasable connection system may form a backing or asubstrate to which the user interface is attached or connected orconnectable thereto.

Preferably, the user interface is provided with one or a pair (or more)of parts or portions connectable with the headgear. More preferably, apair of parts or portions extend from a user interface for connectionwith the headgear.

Preferably the headgear connectable part or portion is substantiallynon-elastic.

Preferably the releasable connection system part or portion forms onepart of a two-part connection system. More preferably the other of thetwo-part connection system may be provided by the frame (or headgear) addefined above.

Preferably the releasable connection system may be a strip or a strap ora length of a connector part of the connection system. More preferablythe strip or strap or length extends to be connectable to, or on, orabout a region of, the frame (or headgear) as defined above.

As discussed above, in one preferred embodiment, advantageously, thereleasable connection system does not utilise pulley strap systems orbuckles. Pulley or buckle type systems can impact on a user's face,particularly an infant face. For example, application of a connection orretention system too tightly on a user's face may contribute toso-called “snub nosing”, such as when forces are applied to the nose,septum or philtrum.

Preferably the releasable connection system enables connection between auser interface and the headgear, whilst reducing the likelihood of theapplication of tension during installation of the user interface to auser in combination with the headgear.

Preferably, a first connector portion may be provided by, or on, aregion of headgear (as defined above), and a second connector portionmay be provided by, or on, a region of (or in attachment or connectionwith) the user interface.

In one embodiment the releasable connection system part or portion ofthe user interface may be of a substantially low profile. In anotherembodiment the releasable connection system part of portion of the userinterface may be of a substantially similar profile to the profile ofthe frame. Preferably the profile is generally substantially planar orsubstantially flat (e.g. in profile).

Preferably the releasable connection system part or portion of the userinterface may be an interference attachment system. More preferably theinterference attachment system part or portion provides for connectionor connectability between the user interface (or a part thereof, or apart connected or attached to a user interface) and one or more of:

the headgear region extending generally about the ear or ears of a user,the headgear region extending generally in front of the ear or ears of auser, the headgear region at or in front of the ear or ears of a user.

Preferably the interference attachment system may be a two-partconnector system as defined above.

Preferably, the user interface may be a gas delivery system or a gasdelivery device. More preferably the user interface may be a device forsupplying of breathable gas to a user.

Preferably the user interface may be any one or any combination of:mask, nasal cannula, oronasal device.

Preferably the user interface is held in a substantially fixed oroperational position when in connection with the headgear.

Preferably the user interface is held in a substantially secure fixed oroperational position when in connection with the headgear.

Preferably the interface may be connectable to a breathing tube.

Preferably the headgear, or user interface, or both, are for an infant.More preferably, the headgear, or user interface, or both, are sized ordesigned for an infant.

In a further aspect, the present invention may broadly comprise anassembly comprising:

a headgear, the headgear as defined above, and a user interface, theuser interface as defined above, the headgear and user interfacereleasably connectable to each other.

Preferably the headgear is supportive of the user interface in anin-situ or installed in-use position with or on a user of the interface.

Preferably the headgear may comprise a first part of a two-partreleasable connection system, and the user interface or a region of (orin attachment or connection with) the user interface comprises a secondof the two-part releasable connection system. More preferably, the firstand second parts may be releasably connectable for retaining of theinterface in a user in-use position, or configuration.

In one embodiment the first part is one of a hook or a loop of a hookand loop type fastener system, and the second part is the other of aloop or a hook for the hook and loop type fastener system.

In another embodiment the two-part connector system is a system ofmagnets. Preferably the first connector part or portion is a firstmagnet or series of magnets, and the second connector part or portion isthe other or a second magnet or series of magnets (e.g. such as magnetsof opposite polarity to the first magnet or series of magnets).

In another embodiment, the two-part connector system may be provided bya two-part adhesive, where the first connector part or portion isprovided with an adhesive that is receivable by the second part orportion, or where the second connector part or portion is provided withan adhesive that is receivable by the first part or portion, or wherethe first part or portion provides for the first of a two-part adhesive,and the second part or portion provides for the second of a two-partadhesive, whereby the bringing together of the first and second parts orportions facilitates or enables adhesion between the two parts.Advantageously, the parts are releasably adherable to each other.

Preferably the first part comprises an adhesive and the second part isreceivable of the adhesive or bondable with the adhesive, or the secondpart comprises an adhesive and the first part is receivable of theadhesive or bondable with the adhesive, or the both the first and secondparts comprises an adhesive or one part of a two-part adhesive.Optionally, such an adhesive is a releasable adhesive system, or is anon-permanent binding or bonding together of adhesive or adhesivereceiver parts.

Preferably the interface may be connectable to a breathing tube.

Preferably the headgear, or user interface, or both, are for an infant.More preferably, the headgear, or user interface, or both, are sized ordesigned for an infant.

The headgear and/or user interface of this invention may be utilised incombination or conjunction with any one or more of the inventionsdescribed in PCT/NZ2011/000218, the contents of which is hereinincorporated by reference.

For the purposes of this specification, reference to “semi-rigid” may bedefined as the headgear (or frame) having a form generally maintained bya structure or by materials selected to generally maintain apre-determined shape or configuration, or which is generallyself-supporting of its own weight and of a shape or form produced orformed during manufacture, construction or assembly of parts. Such adefinition of semi-rigid includes the ability of such material to formto be able to be manipulated into alternative shapes or forms byadjustment of the relative parts or pieces making up the shape or formbeing semi-rigid themselves.

The term “comprising” as used in this specification means “consisting atleast in part of”. When interpreting each statement in thisspecification that includes the term “comprising”, features other thanthat or those prefaced by the term may also be present. Related termssuch as “comprise” and “comprises” are to be interpreted in the samemanner.

This invention may also be said broadly to be embodied in the parts,elements and features referred to or indicated in the specification ofthe application, individually or collectively, and any or allcombinations of any two or more said parts, elements or features, andwhere specific integers are mentioned herein which have knownequivalents in the art to which this invention relates, such knownequivalents are deemed to be incorporated herein as if individually setforth.

The invention is embodied in the foregoing and also envisagesconstructions of which the following gives examples only.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described by way ofexample only and with reference to the drawings, in which:

FIG. 1 shows a headgear according to one embodiment of the inventionready to receive the head of a user.

FIG. 2 shows a headgear in position about the head of a user, with auser interface ready to be positioned on a user and be connected to theheadgear.

FIG. 3 shows an assembly of the headgear and user interface subsequentto interface positioning and connection of the interface with theheadgear.

FIG. 4 shows a headgear with a user interface assembly in connection,demonstrated is connection of the interface to the headgear on a regionof headgear in front of the ears of the user.

FIG. 5 shows a different view of the headgear and interface assembly ofFIG. 4.

FIGS. 6a to 6g show different views of two-part connector systems whichmay be used to connect the headgear and interface.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In one embodiment there is provided a headgear 1. Headgear 1 comprises asemi-rigid frame 2 engageable with the head 3 of a user, and areleasable connection system for releasable connection with a userinterface 4.

The headgear 1 is easily and conveniently removable from, or installableon, the head 3 of a user. Advantageously, the semi-rigid nature of theheadgear allows for resultant minimal handling of a user or user's headduring installation of the headgear or installation of a user interfaceto a user to an operational position. Further, the present inventionprovides for improved security of maintaining the position a userinterface with a user (e.g. prongs remaining in position in the nares ofa user's nose) from the inter-connection of the user interface with theheadgear.

It should be appreciated there are a number of disadvantages andproblems associated with the need for re-positioning of an interface,particularly an infant interface. Included is “snub nosing”, epidermalabrasion, or dermal allergies from traditional tapes or their adhesives.Such problems are also incurred during the cycling of a user betweendifferent treatment options and, traditionally, the subsequent need toremove headgear or tapes or user interfaces and then the installation ofnew equipment and user interfaces or interface positioning headgear orother gear.

Therefore, provision of a headgear that is in a ready-to-receive modefor receiving of a user's head or the user interface (or both) is auseful step in progressing toward reducing the problems users havepreviously been faced with. Further, improving the ease of installation,both in terms of complexity as well as time and effort by a carer (e.g.nurse), is of further benefit.

In a further embodiment headgear 1 comprises a semi-rigid frame 2engageable with the head 3 of a user. The frame 2 extends generallyabout a rear region 5 of a user's head 3, generally about an upperregion 6 of a user's head 3, and generally about an ear 7 or both ears 7of a user. Such a frame 2 further comprises a releasable connectionsystem for releasable connection with a user interface 4.

The releasable connection system can be on or about a region of theframe extending generally about the ear or ears of the user, or can beprovided on or about a region of the frame extending generally at or infront of the ear or ears of the user, such as the region indicated byreference numeral 8.

The releasable connection system can be a two-part connector system. Forexample, a first connector part or portion 9 may be provided by, or on,a region of the headgear, such as for example region 8. A secondconnector part or portion 10 may be provided by, or on, a region of (orin attachment or connection with) a user interface, such as the regionindicated by reference numeral 11.

FIG. 1 shows a headgear 1 in a configuration which is ready to receivethe head 3 of a user.

It will be appreciated that various alternative releasable fastener orreleasable type connection systems can be utilised with this invention.In one preferred embodiment, the first connector part or portion 9 canbe a hook (or one of a hook or a loop) of a hook and loop type fastenersystem, and the second connector part or portion 10 would then be theloop (or other of a loop or a hook) for the complementary part of such ahook and loop type fastener system. In the embodiment shown in FIG. 6g ,both first connector part 9 and second connector part 10 may include amixture of hook and loop parts. Alternatively, a mushroom-type hook andloop fastener system may be used, as shown in FIG. 6 d.

Alternatively, as for example shown in FIG. 6b , adhesive parts may beused where those adhesive parts are connectable to, or receivable of,one another. For example, a first part 9 may be an adhesive part, or onepart of a two-part adhesive connection system; and, the second part 10may be a receiver of the first adhesive part, or the part 10 may be thesecond part of a two-part adhesive system. Such adhesives and parts 9,10 are provided in a form so as to be releasable from each other.

Further examples of releasable connection systems of other embodimentsare shown in FIGS. 6a to 6g . As shown in FIG. 6a , first connector part9 may include an L-shaped retaining hook, which can be inserted into aslot provided in second connector part 10. As shown in FIGS. 6c and 6e ,first connector part 9 may include a dome which is shaped to fit intoone or more slots in second connector part 10. The slots may bekeyhole-shaped, to prevent accidental removal of the dome from the slot.Alternatively, as shown in FIG. 6f , a dome may be provided on secondconnector part 10, with a complementary receiver on first connector part9.

FIGS. 6a-6g illustrate various embodiments of the releasable connectionsystem, including variations of snap-fit or push-fit connection systems.

Advantageously, the releasable connection system utilised is of asubstantially similar profile, or substantially similar to the profileof the frame 2. As shown in the figures, the profile is generally asubstantially planar or substantially flat profile. This beneficiallyallows for increased comfort and minimising pressure sores, whileminimising the visual impact or obstructions that other headgear of moreraised exterior profiles may have or show. Part of the challenge inensuring compliance with gas delivery systems by infant users is thevisual impact that more obtrusive headgear or other systems have on thecarers of the user or parents or guardians of infants.

For example, some prior art headgear systems are relatively obtrusiveboth in their overall size and visual impact. Such obtrusiveness andvisual impact can be distressing to the carers or parents of infantsundergoing treatment supplied by a user interface. It is therefore anaim of this invention to provide an alternative headgear system whichaids in minimising obtrusiveness or visual impact to the carers ofinfants wearing such headgear, and/or which provides for a headgear anduser interface set-up which is easier and less complex that thosesystems provided previously.

The releasable connection system can be of an interference attachmenttype system. For example, such an interference attachment system canprovide for connection or connectability between a user interface 4 (ora part thereof, or a part connected or attached to a user interface) andthe headgear 1, particularly to a region 8 that is either i) extendinggenerally about the ear or ears 7 of the user, or ii) that is extendinggenerally in front of the ear or ears of a user, or iii) at or in frontof the ear or ears of a user.

Various types of releasable connection or attachment systems arecontemplated. One example is that of a hook and loop type system, othersystems may for example include other mechanical quick release systems.

In one preferred embodiment, advantageously, the releasable connectionsystem does not utilise pulley strap systems or buckles. Pulley orbuckle type systems can impact on a user's face, particularly an infantface, such as by pressure sores. For example, application of aconnection or retention system too tightly on a user's face maycontribute to so-called “snub nosing”, such as when forces are appliedto the nose, septum or philtrum. Such “snub nosing” is to besubstantially avoided or reduced. This is uncomfortable for the user(particularly infant users), and distressing for the carer or parents ofthe infant. Therefore, the use of elasticised or stretchable materialsis generally substantially avoided or reduced. For example, the headgearconnectable part or portion of the user interface is of a substantiallynon-elastic part, thereby minimising or reducing the likelihood of anypre-loading of tension build-up between the user interfacing part andthe user or user interfacing part and the headgear. At the same time,the user interface is generally maintained in an operational position(e.g. by maintaining the prongs of a nasal cannula in the nares of auser's nose). Then tension or forces between these parts can also beminimised or reduced.

Further, it is desirable for the releasable connection system to beenabled by a quick fit or quick release system or method for ease ofinstallation or removal of the user interface from a user and to theheadgear 1. Specifically, this invention reduces the likelihood of theneed for application of tension during installation of the userinterface to a user in combination with the headgear. Instead, the userinterface can be placed into its required user interfacing position, thesecond connector or part of the user interface is then able to bequickly and relatively easily located upon the region of the headgear 1adapted to receive the releasable connector region of the userinterface. In this manner, a carer or installer of the user interfacecan, with ease and minimal need for additional help, install a userinterface and locate the interface in its required operational position.

This invention beneficially reduces the likelihood of the need forapplication of adhesive, or adhesive tape, to a user's skin for theinstallation and placement of a user interface into an operationalposition. Adhesive tapes or other dermal adhesive patches, particularlyfor infants, create problems. Problems include, but are not limited to,skin irritation from adhesive chemicals (or adhesive removal chemicals,such as solvents) or tape materials (e.g. due to skin sensitivities),damage to user skin due to repeated application and removal of dermalpatches or tapes for positioning or re-positioning of the interface forthe user. Re-positioning may be required or adjustments may be neededwhere treatment therapies are being cycled (i.e. changed from one typeof treatment to another, and then back again).

Advantageously therefore, this invention provides for a system ofpositioning or locating of a user interface for a user, yet reducing thelikelihood of the problems associated with adhesive tapes attached tothe user's skin.

In positioning of the user interface to the headgear 1, the frame 2 canextend generally about the ears of the user, may partially surround orencircle each, or both, ears, or may wholly surround or encircle the earor both ears. The figures illustrate one embodiment where the ears arewholly encircled by loops. It will be appreciated that alternativeshapes or forms are contemplated.

As more clearly shown by FIGS. 2-5, the headgear 1 can be adjustable.Adjustment allows for fitment to a user's head, such as for improvedanatomical adjustment or differing head size.

The headgear 1 can be adjustable for varying the distance the frame 2extends between the rear region 5 (or region above the nape of a user'sneck) and the portion of the frame that extends generally about the earor ears of a user.

The headgear 1 can alternatively, or in addition, be adjustable forvarying the distance the frame extends between the upper region (or top)6 of a user's head and the portion of the frame that extends generallyabout the ear of ears of a user.

In another alternative, or combination, the frame 2 extending generallyabout the ear or ears of a user can be adjustable, for example anadjustment can be made to the size of the loop about an, or each ear ofthe user. That is, the loop encircling partially or wholly the ear orears of a user can be made smaller or larger, depending on the head 3 ofa headgear user.

The various adjustments above can be made possible by an adjustmentstrap or straps.

In one form, the adjustment strap or one of the adjustment straps may bethat indicated by numeral 12 as being a part of the frame positionablegenerally about the upper region (or top) 6 of the user's head. Strap 12is shown in FIGS. 2 and 3 as components that have reciprocal ones of atwo-part releasable connection system, such as hook and loop components.Alternatively, FIGS. 4 and 5 illustrate an adjustment strap 13 in theform of a buckle arrangement where one of the adjustable straps isinsertable through the buckle and positionable, again for example by useof a releasable connection system, such as that of a hook and loop typesystem being provided on an underside of the strap and connectable withan outward facing side of the buckle side of the strap.

Similar adjustment strap systems can be utilised for an adjustment strapor straps that are a part of the frame 2 and positionable generallyabout the rear region (or region above the nape of the user's neck) 5.

Such adjustment straps can be both a part of the frame 2 andpositionable generally about the upper region (or top) 6 of the user'shead and the frame positionable generally about the rear region (orregion above the nape of the user's neck) 5. Optionally, included can beadjustment around the ear region.

With respect to the head 3 of the user, the rear region 5 is generally alower rear region of the user's head, or generally the region above thenape of the user's neck. The upper region 6 is generally a region aboutthe top of a user's head.

In another embodiment, the frame 2 can be a one-piece or a single partarticle or is a unitary piece of headgear. For example, the frame 2 isnot provided by multiple parts that must be each assembled or connectedtogether to provide the semi-rigid headgear.

In another embodiment, the frame 2 can be assembled into a headgear 1which is semi-rigid, and being effectively a unitary piece of headgear,except for any optional adjustment straps. Optionally, the frame can beformed of all the same material.

Being of a semi-rigid form, it will be appreciated the frame 2 has aninterface 4 which may be releasably connected thereto. Suchself-supporting form of the headgear 1 allows for a distribution of anyforce applied to the headgear 1 from positioning of the interface. Suchsemi-rigid headgear 1 provides a frame 2 about which a user interfacecan be releasable connected thereto, and into which the head 3 of a usercan be inserted.

In another exemplar, the semi-rigid frame can be formed of or from asubstantially non-elastic construction or substantially non-elasticmaterial. In this manner, the frame 2 is formed or constructed so as tobe of a substantially self-supporting shape or configuration. In thismanner, the frame provides a substantially self-supporting frame 2 towhich a user interface 4 (or a part thereof, or a part connected orattached to a user interface) is connectable and supported in-situtherefrom.

The headgear 1 may be constructed to have the frame 2 being of asubstantially planar or substantially flat profile. Such profile canallow for less bulky or obtrusive headgear, or can allow for widerdistribution of any forces about a user's head. The flat or planarprofile may contribute or allow for larger contouring of headgear 1surface about the user's head 3. Similarly, the releasable connectionsystem components are preferably of low profile for similar reasoningand reduced bulkiness.

The frame can be constructed or manufactured from various materials.Materials of a smooth surface or comfortable or soft outer materialdisposition for user may be preferred. Included are those materials ofdermatological sensitivity.

In one embodiment, the headgear 1 can be constructed from non-wovenmaterials, or those polymers providing suitable semi-rigidity. Otherexamples include forming of the frame from thermoplastic orthermosetting polymeric materials, or composites therefrom.Alternatively, the frame may be formed of or from a weldable polymericmaterial. Woven materials that do not fray easily, but which providesuitable semi-rigidity, may also be used.

Polyethylene terephthalate (PET), polyethylene (PE), or polyesters areother contemplated materials which may be formed into a suitably shapedframe 2. Similarly, the frame 2 may be formed from a non-wovenpolyethylene terephthalate (PET)/polyethylene (PE) laminated composite,or a non-woven PET/polyester laminated composite. Other laminatecomposites are also contemplated; suitable are those which provide for alevel of semi-rigidity.

Particularly suited to this invention is the headgear, or userinterface, or both, for infant use. Particularly this is due to theirhead size, need for delicate application of user interfaces or headgearwith minimal disturbance to the infant, and desire to improve the easeof fitment of user interfaces to infants without the need for the morecomplicated systems currently available.

Such user interfaces are desirably those connectable to gas deliverysystems for various breathing gas treatments, e.g. CPAP or otherbreathing gas treatments. User interfaces are any of those suitable asgas delivery devices, particularly those of masks, nasal cannula, orother oronasal devices.

In respect of a further embodiment there is provided a user interface 4.Such a user interface 4 comprises a user interfacing part or portion 14,and a headgear connectable part or portion 16.

In another embodiment however, there is provided the user interface 4comprising the user interfacing part or portion 14, and a headgearconnection system part or portion 16 for releasable connection with areleasable connectable part or portion 15. The headgear connectionsystem may be provided by, or on, a region of (or in attachment orconnection with) the user interface. In this manner, a part of the userinterface or part that may be connected to the user interface part 16may be supported by the releasable connection system part or portion 15of the headgear. See for example FIGS. 2-5 in which the interface 14 issupported or attached to the portion 15. In some embodiments, interface14 may be provided with one or a pair (or more) of parts or portions 16connectable with the headgear, which parts or portions 16 may extendfrom interface 14 for connection with the headgear. In some embodiments,the releasable connectable part or portion 15 may be integral with theuser interfacing part or portion 16 or may be over-moulded with the userinterfacing part or portion 16.

The headgear connection system or its part or portion 16 can be in theform of a backing or a substrate to which the user interface is attachedor connected or connectable thereto. Such a backing or substrate canextend across the whole back or skin-side of the user interface, or itmay be attached or connected (or otherwise formed with) outer peripheraledges or sides of the user interface which then extend sufficient lengthto be enabled to releasably connect with the headgear 1 connectable part15, for example on region 8.

Such part or portion 16 of the interface 4 is capable of supportingsufficient shear and pull forces exerted by positioning of the userinterface and connecting of the part or portion 16 with the headgear 1region 8. Sufficient connection strength or resistance is advantageouslyprovided to limit or reduce the likelihood of an infant removing thepart or portion 16 of the interface 4 from the headgear 1.

Desirably, suitable materials for such part or portion 16 are one ormore of: dermatological appropriate/safe for skin contact (particularlyfor infant skin), smooth surfaced (to reduce or minimise abrasion to auser's skin), generally of a flat or planar profile (i.e. visually lessobtrusive), and may be of a soft outer-most surface for improved feel toa user or carer or parent. Ideally, such materials may not produce lint,or be easily pilled, or easily frayable. Preferred materials alsoinclude those which allow for ease of cleaning.

The figures show the gas delivery tube connected to the user interface4, 14. The gas delivery tube or any other tubes that may be connected toa user interface are optionally able to be freely positioned. Such tubesare not attached to the part 10 of the interface. The ability toindependently position such tubes allows the carer (e.g. nurse) toarrange the tube or tubes in a manner most comfortable for the user toreduce the likelihood of pressure sores or other discomforts and reducethe likelihood of tubular kinking or other such situations.

As with the headgear 1, the headgear connection system part or portion16 of the interface forms one (or a first) part of a two-part connectionsystem. The other, or another, of the two-part connection system is thenprovided by the frame 2 (or headgear 1) as previously defined above. Forexample, one part can be one of a hook or a loop (of a hook and looptype releasable connection system), while the other part can the otherof a loop or a hook, being the reciprocal connection part of such a hookand loop type system.

Such a headgear connection system part or portion of the user interfacecan be for example those which are an interference attachment systemwhere a first part is interferingly attachable or connectable to asecond part. Connection or connectability is desirably between the userinterface (or a part thereof, or a part connected or attached to a userinterface) and a headgear (as as that defined above), such as on or atone or more of: a headgear region extending generally about the ear orears of a user; a headgear region extending generally in front of theear or ears of a user; a headgear region at or in front of the ear orears of a user.

Such headgear connection system part or portion 16 can be a strip or astrap or a length of a connector part of the connection system. Suchstrip or strap or length extends about or from around the user interface14 to be connectable to or on or about a region of a frame, the frame(or headgear) as defined above. The releasable connection system part orpotion 16 can be a flexible, yet non-elasticised part. In this manner,the portion 16 can be attached or connected to the frame 2 about forexample region 8, 15, whilst not being overly stretchable, and thereforeimparting tension forces to the user (particularly for reducing thelikelihood of “snub nosing” problems).

In one preferred embodiment, advantageously, the releasable connectionsystem does not utilise pulley strap systems or buckles. Pulley orbuckle type systems can impact on a user's face, particularly an infantface. For example, application of a connection or retention system tootightly on a user's face may contribute to so-called “snub nosing”, suchas when forces are applied to the nose, septum or philtrum.

Beneficially the releasable connection system enables connection betweena user interface and the headgear 1, whilst reducing the likelihood ofthe application of tension during installation of the user interface toa user in combination with the headgear.

A first connector portion 9 is provided by, or on, a region of headgear(as defined above), and a second connector portion 10 is provided by, oron, a region of (or in attachment or connection with) the userinterface.

Again, with respect to the user interface, the user interface releasableconnection system part or portion is advantageously of a substantiallylow profile, for example it may be a substantially similar profile tothe profile of the frame (e.g. planar or flat).

The user interface may be any of those options mentioned previouslyabove. In this invention, particularly preferred are user interfaceoptions for use with infants. Interfaces are connected to or connectableto gas delivery systems, especially breathable gas systems, and to otherparts of a breathing system or medical circuit.

An assembly of the headgear 1 and user interface 4 provides for a systemof improving comfort of a user and for aiming to improve compliance oftreatment from user interfaces and gas delivery systems. In a furtherembodiment therefore, there is provided an assembly comprising aheadgear 1, the headgear being as previously defined above. The assemblyalso comprises a user interface 4, the user interface being aspreviously defined above. The headgear 1 and user interface 4 arereleasably connectable to each other.

As mentioned above, the headgear 1 is supportive or supporting of theuser interface 4 in an interface 4 in-situ or installed in-use (oroperational) position with or on a user. The headgear 1 is provided witha first or one part of a two-part releasable connection system, and theuser interface 4, 14 or a region 16 of (or in attachment or connectionwith) the user interface comprises a second or other of the two-partreleasable connection system. Such a system allows for the releasableretaining of the interface 4, 14 on a user.

The foregoing description of the invention includes preferred formsthereof. Modifications may be made thereto without departing from thescope of the invention.

1-95. (canceled)
 96. An interface assembly for gas delivery to an airwayof an infant, comprising: a user interfacing portion; at least one firstreleasable connection portion on the interface assembly configured tomake a releasable connection with a headgear such that an inward-facingsurface of the user interfacing portion faces an outward-facing surfaceof the headgear for retaining the user interfacing portion in anoperative position on the infant; and a first breathing tube and asecond breathing tube connected to the user interfacing portion andconfigured to convey gases to or from the infant.
 97. The interface ofclaim 96, wherein the user interfacing portion comprises at least onenasal prong or a mask.
 98. The interface assembly of claim 96, whereinthe at least one first releasable connection portion comprises a pair offirst releasable connection portions, each of the pair of firstreleasable connection portions located on an opposite side of the userinterfacing portion from the other.
 99. The interface assembly of claim98, wherein each of the pair of first releasable connection portionsextends laterally from respective sides of the user interfacing portionto respective positions on the headgear located in front of the infant'sears in use.
 100. The interface assembly of claim 99, wherein the firstand second breathing tubes extend at least partially along therespective ones of the pair of first releasable connection portions.101. The interface assembly of claim 100, wherein the first and secondbreathing tubes are independently positionable.
 102. The interfaceassembly of claim 96, wherein the first breathing tube and the secondbreathing tube extend laterally from respective sides of the userinterfacing portion.
 103. The interface assembly of claim 96, whereinthe at least one first releasable connection portion comprises at leastone part of a two-part releasable connection system with the headgear.104. The interface assembly of claim 103, wherein a second part of thetwo-part releasable connection system is provided by at least one secondreleasable connection portion of the headgear extending generally aboutthe infant's ears.
 105. The interface assembly of claim 103, wherein thetwo-part releasable connection system comprises one of a hook and loopfastening system, a snap-dome fastening system, an adhesive fasteningsystem, a magnetic fastening system, a keyhole-protrusion fasteningsystem and a slot-protrusion fastening system.
 106. The interfaceassembly of claim 96, wherein the at least one first releasableconnection portion does not include a pulley strap, a buckle, or elasticportions.
 107. The interface assembly of claim 96, wherein the at leastone first releasable connection portion is non-elastic.
 108. Theinterface assembly of claim 96, wherein a width of the at least onefirst releasable connection portion greater than a height of the atleast one first releasable connection portion.
 109. The interfaceassembly of claim 96, wherein the at least one first releasableconnection portion is integral with and/or overmoulded onto theinterface.
 110. An interface assembly for an infant, the interfaceassembly comprising: a frame configured to be positioned on the head ofthe infant in use; a breathing interface configured to deliver a flow ofbreathing gases to an airway of the infant, the breathing interfacecomprising first and second breathing tubes; and a releasable connectionsystem for releasable connection of the frame with the breathinginterface, the releasable connection system having a connected state anda disconnected state, the connected state being in which the breathinginterface is attached to the frame with the breathing interface beinglocated outwardly of the frame.
 111. The interface assembly of claim110, wherein first and second breathing tubes extend laterally fromrespective sides of the breathing interface.
 112. The interface assemblyof claim 110, wherein the first and second breathing tubes extend atleast partially along the releasable connection system.
 113. Theinterface assembly of claim 110, wherein the first and second breathingtubes are independently positionable.
 114. The interface assembly ofclaim 110, the releasable connection system comprising a firstconnecting region located on the breathing interface and configured todirectly engage a second connecting region on an ear loop of the frameby laying across the second connecting region, the second connectingregion facing away from the user and the first connecting region facingtoward the user in the connected state.
 115. The interface assembly ofclaim 114, wherein the second connecting region is configured to receivethe first connecting region at any position within the second connectingregion to limit the application of tension to the infant in theconnected state of the breathing interface.